Studies: Bristol's Yervoy,
alone or in combo, improves melanoma results
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[June 02, 2014]
By Bill Berkrot
(Reuters) - New data on
Bristol-Myers Squibb Co's melanoma drug Yervoy,
including fresh results from an effort to combine it
with another promising cancer immunotherapy, suggest it
can improve treatment for patients with both advanced
and slightly earlier stage disease, according to
findings released on Monday.
Yervoy, which takes natural brakes off the immune system to help it
more effectively attack cancer, is approved to treat metastatic, or
stage 4, melanoma - the deadliest form of skin cancer. Cowen and Co
expects the drug to capture annual sales of $1.95 billion by 2020,
as it is approved in new indications and combinations with other
During the annual American Society of Clinical Oncology meeting in
Chicago, Bristol-Myers presented several studies on Yervoy and
nivolumab, its experimental cancer immunotherapy from a highly
promising class called PD-1 inhibitors, both as standalone
treatments and in combination.
In one late-stage study on Yervoy alone, the drug reduced the risk
of melanoma recurrence by 25 percent following surgery compared with
a placebo. The median recurrence-free survival (RFS), or average
time to disease return, following successful surgery to remove
cancerous tumors was 26.1 months for Yervoy compared with 17.1
months for the placebo group. The result was deemed to be
Patients in this study had stage 3 disease in which the cancer had
spread to regional lymph nodes but not yet to other parts of the
"This benefit was observed across all patient sub-groups, including
those who were at highest risk of recurrence," Alexander Eggermont,
the study's lead investigator, said in a statement.
The result could pave the way for the drug's use earlier in the
disease and boost future sales. Current treatment options to reduce
the risk of recurrence following surgery are very limited, Eggermont
The 951-patient Phase III study was the first large trial to look at
Yervoy's effect following complete resection surgery.
Overall survival data was not yet available. But three years after
beginning treatment, an estimated 46.5 percent of Yervoy patients
were free of disease recurrence compared with 34.8 percent in the
Nearly half of the Yervoy patients stopped treatment due to side
effects, which are common with the drug, and there were five
drug-related deaths, or 1.1 percent, researchers reported.
Ron Peck, Bristol's global development leader for Yervoy, said a
high 10 milligram dose was used in the study and may have
contributed to the side effect rate. A 3 mg dose is being used in
LONG-TERM SURVIVAL FOR COMBINATION
Data from a separate, early-stage study of advanced melanoma
patients showed results for Yervoy combined with nivolumab that
researchers found very encouraging.
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At two years, the overall survival rate for the first 53 patients in
the study was estimated to be 79 percent, down only a bit from the
85 percent survival rate reported after one year.
"If this survival data is confirmed in Phase III trials, it's
unprecedented. This is really exciting data," said Dr. Mario Sznol,
a professor of medicine at Yale Cancer Center in New Haven,
Connecticut, and the study's lead investigator.
Having 80 percent of advanced melanoma patients alive at two years
"is almost unheard of," Sznol said in a telephone interview.
Among the 17 patients in the study who received the two drug doses
that Bristol chose to test in its larger, later stage trials the
two-year survival rate was 88 percent.
Seventeen percent of patients in the study had a complete response,
or no detectable cancer. Sznol expects that number to rise.
Immunotherapy results often improve over time as the immune system
learns to fight the disease.
The results were consistent whether or not a patient's tumors
expressed the PD-L1 protein, which helps camouflage them against the
immune system. Patients who are deemed negative for PD-L1 tend to
get little benefit from drugs like nivolumab alone, suggesting the
addition of Yervoy may also help them.
The incidence of serious side effects among the first 53 patients in
the study was about 53 percent and rose to 62 percent with an
additional group of 41 more patients. There was a 23 percent
discontinuation rate due to side effects and one drug-related death,
"These toxicities really are manageable in the clinic," Sznol said.
"If you're getting 79 percent overall survival at two years, the
side effects are clearly worth it."
(Reporting by Bill Berkrot; Editing by Michele Gershberg and Eric
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